Erector Spinae Plane Block in Lumbar Spinal Fusion

NCT04904575 | Recruiting

• 1 other identifier: LOCAL2020-GL01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe or not a reduction in the consumption of morphine within 72 hours of the realization of an erector spinae plane block when preparing for a lumbar spinal fusion.

Conditions

Lumbar Spinal Fusion

Keywords

Erector spinae plane block; consumption of morphine

Outcome Measures

Primary Outcomes (1)

• Consumption of postoperative morphine within 72 hours of the operation.

  72 hours

Secondary Outcomes (4)

• Digital visual scale to assess pain of patient within 72 hours of the operation.

  72 hours

• Onset of nausea and vomiting within 72 hours of the operation.

  72 hours

• Onset of complication within 30 days of the intervention.

  30 days

• Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.

  72 hours

Study Arms (2)

Block

EXPERIMENTAL

The "Block" group will be made up of patients who will benefit from an injection of levobupivacaine for the realization of the erector spinae plane block.

Procedure: Erector spinae plane block

Placebo

PLACEBO COMPARATOR

The "placebo" group corresponds to the reference group, that is to say that it will consist of patients who will benefit from an injection of physiological serum for the realization of the erector spinae plane block.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane block PROCEDURE

Procedure : After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected. Drug : Levobupivacaïne 2,5mg/ml.

Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with medical insurance.
• Patient who received information about study and signes a consent to participate in the study.
• Major patient requiring a lumbar spinal fusion surgery.
• Patient with an ASA score of 1, 2 or 3.

You may not qualify if:

• Minor patient.
• Patient with morphine intolerance
• Patient with allergy to local anesthetics.
• Patient consuming morphine for more than 3 months.
• Pregnant or breastfeeding patient.
• Patient scheduled for cancer surgery or trauma surgery.
• Patient participating in another interventional study.
• Patient with history of lumbar spinal fusion.
• Patient requiring lumbar surgery without arthrodesis.
• Patient requiring lumbar surgery with inter-lamar or inter-epineal stabilization.
• Patient refusing to sign the consent form.
• Patient for whom it is impossible to give informed information.
• Patient under the protection of justice, under curatorship or under tutorship.

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

RECRUITING

Related Publications (14)

• Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019.

  PMID: 31681518 BACKGROUND

• Ren Z, Li Z, Li S, Sheng L, Xu D, Chen X, Wu WKK, Chan MTV, Ho J. Local infiltration with cocktail analgesics during 2 level lumbar spinal fusion surgery: Study protocol of a randomized controlled trial. Medicine (Baltimore). 2019 May;98(19):e15526. doi: 10.1097/MD.0000000000015526.

  PMID: 31083198 BACKGROUND

• Breebaart MB, Van Aken D, De Fre O, Sermeus L, Kamerling N, de Jong L, Michielsen J, Roelant E, Saldien V, Versyck B. A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery. Trials. 2019 Jul 17;20(1):441. doi: 10.1186/s13063-019-3541-y.

  PMID: 31315670 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.

  PMID: 32669870 BACKGROUND

• Ince I, Atalay C, Ozmen O, Ozturk V, Hassan M, Aksoy M, Calikoglu C. Comparison of ultrasound-guided thoracolumbar interfascial plane block versus wound infiltration for postoperative analgesia after single-level discectomy. J Clin Anesth. 2019 Sep;56:113-114. doi: 10.1016/j.jclinane.2019.01.017. Epub 2019 Feb 8. No abstract available.

  PMID: 30743153 BACKGROUND

• Cesur S, Yayik AM, Ozturk F, Ahiskalioglu A. Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. Cureus. 2018 Nov 16;10(11):e3603. doi: 10.7759/cureus.3603.

  PMID: 30680264 BACKGROUND

• Mathiesen O, Dahl B, Thomsen BA, Kitter B, Sonne N, Dahl JB, Kehlet H. A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery. Eur Spine J. 2013 Sep;22(9):2089-96. doi: 10.1007/s00586-013-2826-1. Epub 2013 May 17.

  PMID: 23681498 BACKGROUND

• Davies AF, Segar EP, Murdoch J, Wright DE, Wilson IH. Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Br J Anaesth. 2004 Sep;93(3):368-74. doi: 10.1093/bja/aeh224. Epub 2004 Jul 9.

  PMID: 15247111 BACKGROUND

• Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.

  PMID: 28913452 BACKGROUND

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 BACKGROUND

• Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.

  PMID: 32357842 BACKGROUND

• Nielsen RV, Fomsgaard JS, Dahl JB, Mathiesen O. Insufficient pain management after spine surgery. Dan Med J. 2014 May;61(5):A4835.

  PMID: 24814741 BACKGROUND

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

Study Officials

• Guillaume LONJON, MD

  Clinique Saint Jean, Saint Jean de Védas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie SOULIER

CONTACT

04 67 61 20 71; julie.soulier@capsante.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: January 3, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)